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At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as "what target should be set for the review of new medicines?" and "how can quality be assured?" are now considered to be of critical importance. The 12th CMR International Workshop, held in January 1997, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarizes the many suggestions that were debated at the workshop, and includes chapters on measuring performance, and on the integration of quality into the review process. 163pp.
Kluwer Academic Publishers, 1998, Cloth/Laminated Boards,
Book Condition: Very Good, Jacket Condition: No d/j as Published. .
. 8vo - over 7¾" - 9¾" tall.

Beginning with the introduction of the religion into China, this chronicle depicts the evolution of Buddhism. The career and achievements of the great Kumarajiva are investigated, exploring the famed philosophical treatises that form the core of East Asian Buddhist literature. Providing a useful and accessible introduction to the influential Tien-t'ai school of Buddhism in Japan as well as the teachings of the 13th-century monk Nichiren, this examination places special emphasis on the faith of the Lotus Sutra and the major works of masters such as Hui-su, Chih-i, and Chanjan. From the early translations of the Buddhist scriptures to the persecution of the T'ang dynasty, this exploration illuminates the role of Buddhism in Chinese society, and by extension, in humanity in general. 194pp.Slight crease mark to rear cover.
Middleway Press, 2009, Paperback,
Book Condition: Like New, Jacket Condition: No d/j as Published. .
. 8vo - over 7¾" - 9¾" tall.